Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Existing data does not address the endpoint, see attached Testing Proposal for details.

- Available non-GLP studies: Existing data does not address the endpoint, see attached Testing Proposal for details.

- Historical human data: Existing data does not address the endpoint, see attached Testing Proposal for details.

- (Q)SAR: The available (Q)SAR methods are currently not sufficient to address the complex endpoints
for reproductive and/or development toxicity, see attached Testing Proposal for details.

- In vitro methods: The available in vitro methods are currently not sufficient to address the complex endpoints for reproductive and/or development toxicity, see attached Testing Proposal for details.

- Weight of evidence: There is insufficient weight of evidence from several independent sources to address the endpoint, see attached Testing Proposal for details.

- Grouping and read-across: It is not possible to address this endpoint with grouping of substances and read-across approaches; see attached Testing Proposal for details.

- Substance-tailored exposure driven testing: A REACH Annex XI adaptation based on exposure considerations is not applicable, see attached Testing Proposal for details.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- No, the specific adaptation possibilities of annexes vi to x (and column 2 thereof) of the reach regulation are not adequate to generate the necessary information; see attached Testing Proposal for details.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The most appropriate study is the OECD Guideline for Testing of Chemicals No. 414: Prenatal Developmental Toxicity Study which is replicated in Council Regulation (EC) No 440/208 test method B.31; see attached Testing Proposal for details.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identity : BM1-resin
Lot number / Batch number: 5003-2
Expiry : January 1996
Composition: > 98 % Epoxide resin based on Bisphenol A and epichlorohydrin, blocked with paraphenyl phenol
Appearance: Yellowish powder
Storage conditions: Room temperature
Date received: 9 June 1994





Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion